Validálás & verifikálás

Hasonló előadás

1Validálás & verifikálásIn this lecture, we will discuss validation and verification. Verification is one of the seven principles of HACCP, and the associated activities are established during the HACCP study.Validation is mentioned in the Codex guidelines on the application of the seven HACCP principles, but it is not described how to do it.The words “validation" and "verification” are often misused to cover activities which should not be called validation or verification. In this lecture these terms, as well as terms such as auditing, will be defined.

2Validálás / érvényesítésBizonyítékgyűjtés arra nézve, hogy a HACCP terv elemei hatékonyakCodex 1996A HACCP plan contains a list of hazards, CCPs, critical limits, monitoring and verification procedures etc. All these elements were decided upon during the HACCP study. At a certain CCP specified hazards are controlled with specific control measures, for instance a heat treatment to achieve a certain effect (which should ideally be specified, i.e. a process criterion should be set). Validation means ensuring that e.g. a heat treatment at 72° C for 12 seconds really reduces Salmonella a million fold (6D) on the equipment and in the food under consideration. If a food product should not contain more than a certain level of a hazard at the moment of consumption, challenge studies may need to be performed to validate that under the marketing conditions, and even under slight abuse situations, the hazard levels remain below a specified level. Validation deals with product formulation, processes, storage conditions, preparation and use. Validation is performed before the results of the HACCP study are approved and implemented. Validation may require highly professional skills and may be costly and time consuming. Validation is the responsibility of the producer.

3Bizonyítékgyűjtés arra nézve, hogy a HACCP terv elemei hatékonyakValidálásBizonyítékgyűjtés arra nézve, hogy a HACCP terv elemei hatékonyakA vállalatnak kell elvégeznie a rendszer bevezetésének kezdeti szakaszában, és később, amikor erre szükség vanWhenever a change occurs, a new hazard analysis has to be carried out, because a change might induce a new hazard, or eliminate an existing one (or reduce it to an acceptable level). Clearly the results of this hazard analysis as well as the effectiveness of new control measures (if any) have to be validated. Validation is thus part of the maintenance of the system.FAO/WHO konzultáció 1998 június

4Verifikálás / igazolásA felügyelettől eltérő módszerek, eljárások, vizsgálatok és más értékelések alkalmazása, a HACCP tervnek való megfelelés megállapításáraCodex 1997Verification refers to activities undertaken to check compliance with the plan and its implementation. These activities should be planned ahead, because they should be approved by the responsible person in the establishment at the same time as all other results of the HACCP study.Originally verification was done by the producer to check the effectiveness of the HACCP system. However, since HACCP has been incorporated into legislation and recommended by Codex Alimentarius, regulators have seen verification as their task. This is not correct, as will be explained in the lecture on regulatory assessment.Internationally accepted definitions of the tasks of regulators or law enforcement officers have not been established yet, but the recommendations of a FAO/WHO consultation on the subject (June 1998) will be followed in this lecture. We will use the word verification to refer to: verification as done by the food handler, in accordance with the HACCP plan.Verification is done by the food handler, to determine conformity with the HACCP plan. The word conformity is used when it relates to "compliance" with internal requirements. The word compliance is reserved for an assessment carried out by regulatory authorities (see next overheads).When regulatory agencies test samples of the end-products, this could be seen as verification if the results are also used by the industry. When during a regulatory assessment books and records are reviewed, this again can be seen as verification as long as the results are used by the industry. If results of assessment activities by regulatory authorities are not communicated to and used by the industry these activities should not be called verification.

6MegfelelőségA HACCP terv és az előfeltételek, valamint azok végrehajtása, megfelel a szabályozó előírásoknakIn definitions both of conformity and compliance, it is mentioned that they refer not only to HACCP, but also to its prerequisites. Foods in international trade have to be produced according to General Principles of Hygiene and HACCP. Even for foods which are intended for domestic use, GHP should be the basis, HACCP is complementary to the system, but cannot stand alone. For this reason the word “prerequisites” has been introduced.FAO/WHO konzultáció 1998 június

8Az élelmiszerbiztonság megerősítéseA vállalatok különböző tevékenységeket végeznek annak megállapítására, hogy biztonságos élelmiszert állítottak előEllenőrzik, hogy:a dolgot elvégeztéka dolgot megfelelően végezték ela megfelelő dolgot végezték ela megfelelő eredményhez jutottakThis lecture attempts to clarify validation and verification activities.A number of activities are carried out by industry to ascertain the safety of a product.We will see which of them can be called validation and which verification.The word confirmation is used in the sense of Webster’s Dictionary: established as true..

9Az élelmiszerbiztonság megerősítése (folyt.)a dolgot elvégeztékpasztörizálása dolgot megfelelően végezték elidő & hőmérséklet elérésea megfelelő dolgot végezték elidő & hőmérséklet megfelelőa megfelelő eredményhez jutottakL. monocytogenes esetén 6DTo illustrate this, we take the example of milk pasteurization.We can check whether milk was pasteurized by testing a sample for phosphatase activity.The heat treatment can be checked by looking at the thermograph and the flow meter (pump speed).The objective of the treatment is to kill a sufficient number of vegetative forms of pathogens. We can check with challenge tests or data from models or literature, whether the applied time/temperature combination should achieve this.Finally the milk can be tested for surviving pathogens, but it is more appropriate to test for coliforms or other indicators of a correct heat treatment.

10Az élelmiszerbiztonság megerősítéseEllenőrizni kell, hogy:a dolgot elvégezték verifikálása dolgot megfelelően végezték el felügyeleta megfelelő dolgot végezték el validálás/verifikálása megfelelő eredményhez jutottak validálásClearly the first activity is verification; the activity is done after the milk is produced.The next activity is monitoring. When things are getting out of control, adjustments can still be made in time.The third activity is validation as well as verification, depending on the timing. When it is done after the production run it is verification; if it is done before production starts it is validation.The last activity is clearly validation, it is certainly not correct to bring products on the market when results of the control measures have not been shown to meet objectives.

11Az ellenőrzés hatékonysága a CCP pontokon függ:A veszély helyes identifikálásátólA CCP alkalmasságátólAz ellenőrző mérés megfelelőségétőlA kritikus határérték korrektségétőlAttól a képességtől, hogy a felügyeleti eljárás képes-e időben jelezni a normálistól való eltéréstA felügyeleti eljárás gyakoriságának alkalmasságátólAt a CCP a hazard should be controlled. The effectiveness of this control depends on many factors and parameters, some of them are listed in this overhead.First of all the identified hazard should be the right one, and the CCP should be appropriate in dealing with this hazard. If Listeria can grow in a drain next to an open line, controlling the drain is more effective than prevention of contamination of the product in the adjacent line. Cleaning the drain frequently, and drying directly afterwards if possible, would be an adequate control measure.Time and temperature as critical limits were already discussed.It is clear that a monitoring method should detect a deviation in time, i.e. before a product reaches the consumer, but preferably as soon as a change from normality indicates that adjustments should be made.

12“Szándékos biztonság”VeszélymegelőzésTermékjellemzőkTesztek vitatásaTárolási tesztekKözlekedési útvonalak elendezéseGyártási paraméterekTisztítási, fertőtlenítési rendszerThe safety of foods is achieved by “safety by design”.The activities listed in this overhead may need to be carried out before production starts. Challenge and storage tests may be used for validation. Process parameters and cleaning and disinfection systems may need to be validated. Validation is an integral part of product development and process design.A validálás a „szándékos biztonság” része

13Az igazolás magában foglaljaEllenőrzési rendszer:A 7 alapelvet megfelelően alkalmaztákA HACCP tervet megfelelően és következetesen megvalósítottákHatékonyság megerősítése:A rendszer biztosítja az elvárt paramétereketVerification comprises checking system conformity and confirmation of effectiveness of the system.System conformity means that the seven principles have been correctly applied and that the HACCP plan is correctly and consistently implemented. It is not an approval of the system, i.e. that all the hazards have been correctly identified, that critical limits have been correctly chosen etc. It only means that the system was understood and the resulting activities put into action.Effectiveness confirmation means that evidence is sought to confirm that the system delivers what is expected.

14Verifikálási tevékenységekA HACCP rendszer és nyilvántartásainak felülvizsgálataVevői reklamációk felülvizsgálataVégtermék-vizsgálatokA validálási dokumentumok felülvizsgálataAz előírt követelményektől való eltérés ésazok következményeinek felülvizsgálataAnnak megerősítése, hogy a CCP szabályozásalatt állThese activities are mentioned in the Codex text as examples of verification. "Review" means a retrospective view or survey of past events, experiences etc.A review should show whether unacceptable deviations were followed up and/or whether CCPs were kept under control. The review of consumer complaints can demonstrate that deviations were not detected, and thus that things have to be changed: the system did not deliver what was expected. If the review shows that CCPs were not always monitored as foreseen, or that instruments used for monitoring were not accurate, the system or its implementation has to be improved.End-product testing may provide some evidence that the plan was effective, and that objectives were achieved, but especially as regards control of pathogens it is a poor verification tool, as will be explained later.Validation itself is not the same as verification as was explained before, however review of validation data can certainly be regarded as a verification activity.

15Az igazolás folyamatos tevékenységet jelentVerifikálásAz igazolás folyamatos tevékenységet jelentAmennyiben a meglévő folyamatokban bárminemű változás/változtatás következik be, a veszélyelemzést ismételten el kell végezni, az eredményeket verifikálni, a változások/változtatások hatékonyságát a HACCP tervben validálni szükségesA felügyeleti nyilvántartásokat, eltérésekről szóló jelentéseket, a nyersanyag és végtermék-ellenőrzés dokumentumait, a vevői reklamációkat, stb. rendszeresen felül kell vizsgálniA nyilvántartásoknak minden tevékenységet tartalmazniuk kellVerification is an ongoing activity. A new hazard analysis is necessary after changes in raw materials, processing conditions, line lay-out, distribution conditions, preparation and use etc. The outcome of such an analysis may need to be validated and verified.As a consequence of trends detected in monitoring results, results of raw material and end product testing etc., changes may be made which need to be verified.Records of all these verification activities should be kept for examination by external auditors or government inspectors.

16Igazolási adatlap Mit Miért Mikor Hogyan Ki Termék- ellenőrzéscoliformokraFelügyeletiirányMiértPast. &Recont.KontrollJavításMikorMinden batch végénHó végénHogyanLabora-tóriumiinstrukciókGrafikonKiLaborQA Man.In this overhead two examples are given concerning verification activities, and how established verification activities could be summarized for implementation.

17Milyen kérdéseket kell feltenni az igazolás jóváhagyása előtt1. Helyesen határozták meg a lehetséges és reálisveszélyeket ?2. A szabályozó intézkedés megelőzi, kiküszöbölivagy elfogadható szintre csökkenti a veszélyeket?In summary these questions cover the essence of verification. They speak for themselves and do not need to be further explained. If they are however, not well understood, some of the foregoing overheads may need to be explained or discussed again.3. A helyesbítő tevékenység helyreállítják aszabályozást?4. Az eltérést mutató terméket időben észreveszik,hogy az ne juthasson el a fogyasztóhoz ?